COVID-19 Vaccine, mRNA, Bivalent (Pfizer-BioNTech)

Information from clinical trials is available at this time to support the use of COVID-19 vaccine, mRNA, bivalent (Pfizer-BioNTech) to prevent COVID-19.

The FDA has approved an EUA for the COVID-19 vaccine, mRNA, bivalent (Pfizer-BioNTech) for individuals 6 months of age or older who have not received any previous COVID-19 vaccine, to be given as:

• a 3-dose series for individuals 6 months through 5 years given at 0, 3 weeks and then at least 8 weeks after the second dose
• a single dose for individuals 5 through 64 years of age
• a single dose for individuals 65 years of age and older with an additional dose 4 months or more later

The FDA has also approved an EUA for the COVID-19 vaccine, mRNA, bivalent (Pfizer-BioNTech) for individuals 6 months through 4 years of age who have previously been vaccinated against COVID-19 with COVID-19, mRNA, monovalent (Pfizer-BioNtech) (no longer authorized for use in the United States) to be given as one dose at least 3 weeks after the COVID-19, mRNA, monovalent dose followed by another dose at least 8 weeks later. If the individual had received more than 1 dose of the previous vaccine, at least two months should pass since the last dose before the COVID-19, mRNA, bivalent is given.

The FDA has also approved an EUA for the COVID-19 vaccine, mRNA, bivalent for individuals 5 years of age and older who have previously been vaccinated with 1 or more dose of any monovalent COVID-19 vaccine given as a single dose at least 2 months after their last dose of the monovalent COVID-19 vaccine. For individuals over 65 years of age, one additional dose may be given at least 4 months after the first dose of COVID-19, mRNA, bivalent vaccine.

Talk to your doctor or vaccine provider about the risks and benefits of receiving this medication.

COVID-19 disease is caused by a coronavirus called SARS-CoV-2. You can get COVID-19 through contact with another person who has the virus. It is predominantly a respiratory (lung) illness, but it can also affect other organs. People with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness leading to death. Symptoms may appear 2 to 14 days after exposure to the virus. Symptoms may include: fever, chills, cough, shortness of breath, fatigue, muscle or body aches, headache, loss of taste or smell, sore throat, congestion, runny nose, nausea, vomiting, or diarrhea.

The COVID-19 mRNA, monovalent and bivalent vaccines will be given to you as an injection into the muscle.

Tell your vaccine provider about all of your medical conditions, including if you:

• have any allergies.
• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart).
• have a fever.
• have a bleeding disorder or are taking a blood thinner such as warfarin (Coumadin, Jantoven).
• have a weakened immune system or are on a medicine that affects your immune system.
• are pregnant or plan to become pregnant.
• are breast-feeding.
• have received another COVID-19 vaccine.
• have ever fainted in association with an injection.
• have had a severe allergic reaction after a previous dose of this vaccine.
• have had a serious allergic reaction to any ingredient in this vaccine.

In an ongoing clinical trial, the COVID-19, mRNA, bivalent vaccine (Pfizer-BioNTech) has been shown to prevent COVID-19 against the two known circulating strains of the virus (original and Omicron). How long you are protected against COVID-19 is currently unknown.

Side effects that have been reported with the Pfizer-BioNTech COVID-19 vaccine include:

• non-severe allergic reactions such as rash, itching, hives, or swelling of the face
• injection site pain, swelling, and redness
• tiredness
• headache
• muscle pain
• chills
• joint pain
• fever
• nausea
• feeling unwell
• swollen lymph nodes
• decreased appetite
• diarrhea
• vomiting
• arm pain
• fainting at the time you receive your injection

There is a remote chance that the Pfizer-BioNTech COVID-19 vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Pfizer-BioNTech COVID-19 vaccine.

Signs of a severe allergic reaction can include:

• difficulty breathing
• swelling of your face and throat
• a fast heartbeat
• a bad rash all over your body
• dizziness and weakness

Myocarditis and pericarditis have occurred in some people who have received the Pfizer-BioNTech COVID-19 vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days after getting the second dose of the Pfizer-BioNTech COVID-19 vaccine. The chance of having this occur is very low.

You should seek medical attention right away if you have any of the following symptoms after receiving the Pfizer-BioNTech COVID-19 vaccine:

• chest pain
• shortness of breath
• feelings of having a fast-beating, fluttering, or pounding heart

These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 vaccine is still being studied in clinical trials.

What you should do about side effects:

• If you experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
• Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away.
• Report vaccine side effects to FDA/CDC Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online tohttps://vaers.hhs.gov/reportevent.html. Please include either "COMIRNATY (COVID-19 Vaccine, mRNA)", "Pfizer-BioNTech COVID-19 Vaccine EUA", or "Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA" as appropriate, in the first line of box #18 of the report form.
• In addition, you can report side effects to Pfizer Inc. at http://www.pfizersafetyreporting.com or at 1-800-438-1985.
• You may also be given an option to enroll in v-safe. V-safe is a new voluntary smartphone-based tool that uses text messaging and web surveys to check in with people who have been vaccinated to identify potential side effects after COVID-19 vaccination. V-safe asks questions that help CDC monitor the safety of COVID-19 vaccines. V-safe also provides second-dose reminders if needed and live telephone follow-up by CDC if participants report a significant health impact following COVID-19 vaccination. For more information on how to sign up, visit: http://www.cdc.gov/vsafe.

Certain children between the ages of 6 months and 4 years who are considered immunocompromised (have a weakened immune system), may receive a fourth dose of the Pfizer-BioNTech COVID-19 vaccine at least 1 month after the 3rd dose of either the monovalent or bivalent form of COVID-19, mRNA vaccine. For individuals 5 years of age and older considered immunocompromised, a single additional dose of COVID-19 vaccine, mRNA, bivalent may be administered at least 2 months following the initial dose.

No. The Pfizer-BioNTech COVID-19 vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.

When you get your first dose, you will get a vaccination card to show you when to return for your next dose(s) of Pfizer-BioNTech COVID-19 vaccine. Remember to bring your card when you return.

The vaccination provider may include your vaccination information in your state/local jurisdiction's Immunization Information System (IIS) or other designated system. This will ensure that you receive the same vaccine when you return for your next dose of Pfizer-BioNTech COVID-19 vaccine. For more information about IISs visit: https://www.cdc.gov/vaccines/programs/iis/about.html.

You can learn more by:

• Ask the vaccination provider.
• Visit CDC at https://www.cdc.gov/coronavirus/2019-ncov/index.html.
• Visit FDA at http://bit.ly/3qI0njF.
• Contact your local or state public health department.

No. At this time, the provider cannot charge you for a vaccine dose and you cannot be charged an out-of-pocket vaccine administration fee or any other fee if only receiving a COVID-19 vaccination. However, vaccination providers may seek appropriate reimbursement from a program or plan that covers COVID-19 vaccine administration fees for the vaccine recipient (private insurance, Medicare, Medicaid, HRSA COVID-19 Uninsured Program for non-insured recipients).

Individuals becoming aware of any potential violations of the CDC COVID-19 Vaccination Program requirements are encouraged to report them to the Office of the Inspector General, U.S. Department of Health and Human Services, at 1-800-HHS-TIPS or TIPS.HHS.GOV.

The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one year from the date of receiving the vaccine. To learn more about this program, visit http://www.hrsa.gov/cicp/ or call 1-855-266-2427.